Urodynamic Stress IncontinenceNCT04109157
Test-retest Reliability of 20-minute Pad Test
A study testing 20-minute pad test in people with Urodynamic Stress Incontinence, run by National Taiwan University Hospital.
Trial summary
In our department, we performed a 20-minute pad test since 2005. The 20-minute pad test uses 250 mL of sterile water instilled directly into an empty bladder with a catheter rather than relying on walking for 30 minutes at the beginning of a one-hour pad test. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Urodynamic Stress Incontinence
- What is being tested?
- 20-minute pad test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 31 Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS)
Who cannot join
- SUI but not USI
- Urinary tract infection
- Pelvic inflammation or malignancy
- Long term urinary catheterization
About this study
Official title: Test-retest Reliability of 20-minute Pad Test Infused With Strong-desire Amount of Water In Bladder in Women With Urodynamic Stress Incontinence
In our department, we performed a 20-minute pad test since 2005. The 20-minute pad test uses 250 mL of sterile water instilled directly into an empty bladder with a catheter rather than relying on walking for 30 minutes at the beginning of a one-hour pad test. We previously reported that 20-minute pad test has better sensitivity than the one-hour pad test in women with stress urinary incontinence (SUI). Due to the different bladder capacity in each patient, we tried to infuse strong-desire (SD) amounts of water that can more precisely reflect the full bladder capacity in each patient. We found an even better sensitivity when the 20-minute pad test was infused with SD amount of water in women with SUI compared with infusion with 250 mL of water in the bladder.
As to short-term pad test, previous studies had some concerned about the reliability and reproducibility. Thus, undertaking our previous two studies, we want to evaluate the test-retest reliability of the 20-minute pad test infused with SD amount of water in bladder in women with SUI.
Read the detailed description
Between August 2007 and December 2010, a total of 89 women with SUI were recruited. Of them, 67 (75%) women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study. Our 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage. Each woman underwent a complete UDS before pad test, including uroflowmetry, filling (with a rate of 60mL H2O/min of 35℃ distilled water) and voiding cystometry, and stress urethral pressure profile using a two-way NO.7 French flexible Foley catheter with the SD amount in the bladder. The retest twenty-minute pad test infused with SD amount water in bladder was performed within one week after first pad test. The activities that the patients underwent were the same in test and retest 20-minute pad tests. USI was diagnosed if involuntary urine leakage was noted during filling cystometry, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. Detrusor overactivity (DO) was diagnosed if involuntary detrusor contraction occurred during filling cystometry. The exclusion criteria included no obvious USI, clinically significant urinary tract infection (UTI), and chronic pelvic inflammation. The procedures and study purpose were completely explained to the participants with fully informed consent.
A multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston, Tex) was used. All terminology conformed to the standards recommended by the ICS and Urodynamic Society. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid inter-observer variability.
STATA software (Version 11.0; Stata Corp, College Station, TX, USA) was used for statistical analyses. Spearman rank-correlation coefficient and intraclass correlation coefficient were tested for correlation and reliability of the test and retest results. The Wilcoxon signed rank test was tested for the difference of the test and retest. A p value of less than 0.05 was considered statistically significant.
- Conditions
- Urodynamic Stress Incontinence
- Being tested
- 20-minute pad test
- Keywords
- Pad test, Test-retest reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-minute pad testDiagnostic test
Our 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Other | Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study. Receives: Diagnostic Test: 20-minute pad test |
What is being measured
The primary outcome is the main question the study is designed to answer.
20-minute pad test
The pad weight or 20-minute pad test
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Aug 2007
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Urodynamic Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109157
- Sponsor's protocol ID
- 200612063R
- Status last verified
- Aug 2019
- First submitted
- 23 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sutherst J, Brown M, Shawer M. Assessing the severity of urinary incontinence in women by weighing perineal pads. Lancet. 1981 May 23;1(8230):1128-30. doi: 10.1016/s0140-6736(81)92299-6.
PubMed 6112488Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardisation of terminology of lower urinary tract function. The International Continence Society Committee on Standardisation of Terminology. Scand J Urol Nephrol Suppl. 1988;114:5-19. No abstract available.
PubMed 3201169Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Ferreira CH, Bo K. The Pad Test for urinary incontinence in women. J Physiother. 2015 Apr;61(2):98. doi: 10.1016/j.jphys.2014.12.001. Epub 2015 Mar 3. No abstract available.
PubMed 25744851Wu WY, Sheu BC, Lin HH. Comparison of 20-minute pad test versus 1-hour pad test in women with stress urinary incontinence. Urology. 2006 Oct;68(4):764-8. doi: 10.1016/j.urology.2006.04.018.
PubMed 17070349Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.
PubMed 23797972Lose G, Rosenkilde P, Gammelgaard J, Schroeder T. Pad-weighing test performed with standardized bladder volume. Urology. 1988 Jul;32(1):78-80. doi: 10.1016/0090-4295(88)90462-1.
PubMed 3388665Wu WY, Sheu BC, Lin HH. Twenty-minute pad test: comparison of infusion of 250 ml of water with strong-desire amount in the bladder in women with stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):121-5. doi: 10.1016/j.ejogrb.2007.02.030. Epub 2007 May 30.
PubMed 17540494Simons AM, Yoong WC, Buckland S, Moore KH. Inadequate repeatability of the one-hour pad test: the need for a new incontinence outcome measure. BJOG. 2001 Mar;108(3):315-9. doi: 10.1111/j.1471-0528.2001.00069.x.
PubMed 11281474
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability of 20-minute Pad Test Infused With Strong-desire Amount of Water In Bladder in Women With Urodynamic Stress Incontinence
- ClinicalTrials.gov ID
- NCT04109157
- Acronym / sponsor ID
- 200612063R
- Conditions
- Urodynamic Stress Incontinence
- Keywords
- Pad test, Test-retest reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our department, we performed a 20-minute pad test since 2005. The 20-minute pad test uses 250 mL of sterile water instilled directly into an empty bladder with a catheter rather than relying on walking for 30 minutes at the beginning of a one-hour pad test. We previously reported that 20-minute pad test has better sensitivity than the one-hour pad test in women with stress urinary incontinence (SUI). Due to the different bladder capacity in each patient, we tried to infuse strong-desire (SD) amounts of water that can more precisely reflect the full bladder capacity in each patient. We found an even better sensitivity when the 20-minute pad test was infused with SD amount of water in women with SUI compared with infusion with 250 mL of water in the bladder.
As to short-term pad test, previous studies had some concerned about the reliability and reproducibility. Thus, undertaking our previous two studies, we want to evaluate the test-retest reliability of the 20-minute pad test infused with SD amount of water in bladder in women with SUI.
Detailed description
Between August 2007 and December 2010, a total of 89 women with SUI were recruited. Of them, 67 (75%) women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study. Our 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage. Each woman underwent a complete UDS before pad test, including uroflowmetry, filling (with a rate of 60mL H2O/min of 35℃ distilled water) and voiding cystometry, and stress urethral pressure profile using a two-way NO.7 French flexible Foley catheter with the SD amount in the bladder. The retest twenty-minute pad test infused with SD amount water in bladder was performed within one week after first pad test. The activities that the patients underwent were the same in test and retest 20-minute pad tests. USI was diagnosed if involuntary urine leakage was noted during filling cystometry, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. Detrusor overactivity (DO) was diagnosed if involuntary detrusor contraction occurred during filling cystometry. The exclusion criteria included no obvious USI, clinically significant urinary tract infection (UTI), and chronic pelvic inflammation. The procedures and study purpose were completely explained to the participants with fully informed consent.
A multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston, Tex) was used. All terminology conformed to the standards recommended by the ICS and Urodynamic Society. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid inter-observer variability.
STATA software (Version 11.0; Stata Corp, College Station, TX, USA) was used for statistical analyses. Spearman rank-correlation coefficient and intraclass correlation coefficient were tested for correlation and reliability of the test and retest results. The Wilcoxon signed rank test was tested for the difference of the test and retest. A p value of less than 0.05 was considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Other | Diagnostic Test: 20-minute pad testWomen who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS)
Key exclusion criteria (4 listed)
- SUI but not USI
- Urinary tract infection
- Pelvic inflammation or malignancy
- Long term urinary catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20-minute pad testOur 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage. | Diagnostic test | Study population |
Primary outcome
20-minute pad test
Time frame: One week
The pad weight or 20-minute pad test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Background: PubMed 6112488Sutherst J, Brown M, Shawer M. Assessing the severity of urinary incontinence in women by weighing perineal pads. Lancet. 1981 May 23;1(8230):1128-30. doi: 10.1016/s0140-6736(81)92299-6.
- Background: PubMed 3201169Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardisation of terminology of lower urinary tract function. The International Continence Society Committee on Standardisation of Terminology. Scand J Urol Nephrol Suppl. 1988;114:5-19. No abstract available.
- Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background: PubMed 25744851Ferreira CH, Bo K. The Pad Test for urinary incontinence in women. J Physiother. 2015 Apr;61(2):98. doi: 10.1016/j.jphys.2014.12.001. Epub 2015 Mar 3. No abstract available.
- Background: PubMed 17070349Wu WY, Sheu BC, Lin HH. Comparison of 20-minute pad test versus 1-hour pad test in women with stress urinary incontinence. Urology. 2006 Oct;68(4):764-8. doi: 10.1016/j.urology.2006.04.018.
- Background: PubMed 23797972Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.
- Background: PubMed 3388665Lose G, Rosenkilde P, Gammelgaard J, Schroeder T. Pad-weighing test performed with standardized bladder volume. Urology. 1988 Jul;32(1):78-80. doi: 10.1016/0090-4295(88)90462-1.
- Background: PubMed 17540494Wu WY, Sheu BC, Lin HH. Twenty-minute pad test: comparison of infusion of 250 ml of water with strong-desire amount in the bladder in women with stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):121-5. doi: 10.1016/j.ejogrb.2007.02.030. Epub 2007 May 30.
- Background: PubMed 11281474Simons AM, Yoong WC, Buckland S, Moore KH. Inadequate repeatability of the one-hour pad test: the need for a new incontinence outcome measure. BJOG. 2001 Mar;108(3):315-9. doi: 10.1111/j.1471-0528.2001.00069.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Hsiung Lin, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 20-minute pad test in people with Urodynamic Stress Incontinence, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20-minute pad test (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109157, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.